MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST; PTA BALLOON DILATATION CATHETER

Catalog Number CQ5074

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure of the artificial blood vessel in the left forearm, the pta balloon allegedly could not be retracted.It was further reported that the balloon was allegedly broken.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4: (expiration date: 08/2025).H11: section a: through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: CONQUEST
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18966919
• MDR Text Key: 338452639
• Report Number: 2020394-2024-00387
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ5074
• Device Lot Number: REGW2717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female